18 May 2012 - Stem cell company Osiris Therapeutics Inc (NASDAQ:OSIR) reported on Thursday the receipt of market authorisation from Health Canada for its stem cell therapy Prochymal (remestemcel-L) for the treatment of acute graft-vs-host disease (GvHD) in children.

The company added this historic decision marks the world's first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD, a devastating complication of bone marrow transplantation that kills up to 80% of children affected, many within just weeks of diagnosis.

This approval in Canada was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. The survival benefit was most pronounced in patients with the most severe forms of GvHD.

According to the company, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

In conjunction, Health Canada's decision will provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.